Chronic Pelvic Pain Syndrome, Pudendal Neuralgia
Conditions
Brief summary
Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. This pain syndrome is difficult to diagnose and patients with pudendal neuralgia may present to providers with refractory chronic pelvic pain. Pudendal nerve infiltration or pudendal nerve block (PNB) serves as a diagnostic tool and treatment modality for patients with this condition. To date, there are no published randomized controlled trials comparing imaging-guided PNB to transvaginal finger-guided PNB. While one can assume that image-guided nerve blocks will provide better accuracy for injection and potentially better efficacy in pain relief as a result, no published data exists comparing the outcomes and efficacy between modalities. The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger-guided pudendal nerve block versus bilateral fluoroscopy-guided trans gluteal pudendal nerve block for patients with pudendal neuralgia.
Detailed description
Primary objective: Determine the efficacy of pain relief comparing the change in Visual Analog Scale (VAS) from baseline to 6 weeks in women randomized to Transvaginal PNB (without imaging) versus Trans gluteal fluoroscopy-guided PNB. Upon completion of 6-week follow-up, participants will be given the option to crossover to the alternative treatment arm Secondary Objectives: Characterize the effect of either pudendal nerve block approach using the following validated questionnaires * PROMIS-29 (degree of pain intensity and bother across health domains) * Pain catastrophizing scale (emotional and cognitive impact of pain) * Short-form McGill (qualitative pain) * Patient satisfaction with medical care * Baseline demographics * Baseline VAS * Adverse events * Determine the time to peak pain relief and duration of injection pain relief
Interventions
DRUGBupivacaine injection
Transvaginal: Palpation 1 cm superior and medial to ischial spine to locate pudendal nerve. 22 gauge spinal needle with trumpet will be placed at this location. Upon negative aspiration, 10 mL of 0.25% bupivacaine will be injected bilaterally. Fluoroscopic: Anesthesia Pain medicine fluoroscopy guided injection of 5 mL 0.25% bupivacaine bilaterally in the area of the pudendal nerve based on surrounding landmarks
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Patients will be unable to remain masked to treatment intervention. Procedurists will also be unable to remain masked.
Intervention model description
Parallel prospective randomized non-inferiority trial with option for cross-over
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women \>18 years * English speaking/reading * Diagnosis of pudendal neuralgia OR chronic pelvic pain with pain in the distribution of the pudendal nerve for 3 months or longer * Minimum pain/bother score of 4/10 * Desire for pudendal nerve block
Exclusion criteria
* Contraindication to pudendal nerve block (examples: skin or vaginal infection, bupivacaine allergy, uncorrected coagulopathy) * Pregnant or intending to become pregnant during the study * Pudendal nerve block from any route within the last 3 months * Major pelvic surgery within the last 3 months (examples: hysterectomy, prolapse repair, midurethral sling) * Neurologic disease affecting the perineum (examples: spinal cord injury, multiple sclerosis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in Visual Analog Scale (VAS) for pain | 6 weeks | VAS will be obtained at baseline, post-procedure, weekly until 6 weeks, scale is 0-100 mm with higher scores indicated more pain severity |
Countries
United States
Contacts
Primary ContactLaurel Carbone, MD
Backup ContactSean Francis, MD
Outcome results
None listed